The Importance of Being Washington – The GAO Outlines FDA Reforms

Not the man, the city.   On Sunday, January 25, the Washington Post carried an article entitled "The Height of Power – As Other American Fiefdoms Fade, Washington Looms Larger than Ever."  It was a very interesting article analyzing the current environment and the way that now, more than ever perhaps, government is going to be involved across industries in business.   There will be a Car Czar looming over Detroit – the direction of new energy sources and the shape up of the power grid will have growing dominion over energy, and of course, as banks continue to flail, Washington will have a greater say in banking.

Something not noted in the article, but also true is that Washington is going to have a greater role in how we use, purchase, test for and market pharmaceutical, device and biotech products.  Already, there have been several bills introduced into the 111th Congress, recycled from the 110th, that would allow for the importation of prescription drugs and that would turn lights on respecting the relationships between manufacturers and medical prescribers.  There will be legislation introduced seeking to make companies proactive on finding and investigating adverse events, on limiting DTC and adding additional enforcement to Phase IV trials and REMS programs.  For the medicines industry, it is going to be a time of unprecedented government regulation.

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In fact, last week the GAO issued a report that contains somewhat of a blueprint for what needs to be done.  In a report that designates agencies in need of government attention, the Food and Drug Administration was added as a new High Risk Area.   In a section of the report entitled "Protecting Public Health Through Enhanced Oversight of Medical Products", four issues in particular are cited:
  • The Inspection of Foreign Manufacturers - FDA’s inspections of drug and device manufacturers overseas are further challenged by unique circumstances posing difficulties that are not encountered domestically. For example, FDA does not have a dedicated staff to conduct foreign inspections. It is unable to conduct unannounced inspections of foreign manufacturers, as it sometimes does with domestic manufacturers. It also lacks the flexibility to easily extend foreign inspections if problems are encountered, due to the need to adhere to an itinerary that typically involves multiple inspections in the same country. Language barriers can add to the difficulty of these inspections. FDA does not routinely provide translators to its inspection teams. Instead, they may have to rely on an English-speaking representative of the establishment being inspected, rather than an independent translator. Although FDA has proposed initiatives to improve foreign inspections, including opening a limited number of overseas offices, it is too early to tell whether they will be effective. We recently recommended that FDA, among other things, improve the data it uses to manage the foreign drug inspection program and conduct more inspections of foreign establishments. HHS agreed that FDA should conduct more inspections of foreign establishments and elaborated on its efforts to improve its databases, but it did not provide specific time frames for accomplishing these tasks.
  • Monitoring Post Marketing Safety -  Although FDA has made some organizational and policy changes to its management and oversight of postmarket safety and received new authority to require and enforce that drug manufacturers conduct postmarket studies, when deemed necessary, we remain concerned with FDA’s progress and the potential public health consequences if FDA is not able to make decisions quickly.
  • The Review of Promotional Materials for Medical Products - We have also found the agency does not track information on its reviews and cannot determine how many materials it reviews in a given year. In addition to these reviews, FDA is limited in its ability to identify violations that would not be identified through its review of submitted material—for instance, presentations by drug companies at medical conferences and discussions between doctors and sales representatives in doctors’ offices. We found that when FDA does identify potentially violative promotional materials—such as those that promote the use of a drug for a broader range of patients than it has been found to be safe and effective for—it has taken the agency months to ask that the drug companies cease their dissemination of these materials and more time for the companies to respond to FDA’s request. Yet, multimillion-dollar settlements between the Department of Justice and drug manufacturers regarding allegations that manufacturers illegally promoted drugs by distributing violative advertising materials continue to point to the need for greater FDA scrutiny. We have recommended that FDA systematically prioritize materials for review and track these materials. HHS disagreed with our finding that promotional materials are not systematically prioritized by FDA. HHS also disagreed with our recommendation that FDA should track these materials. We continue to believe our recommendations merit action.
  • Overseeing Clinical Trials As part of its duties, FDA is charged with overseeing clinical trials of investigational new drugs before they are approved for marketing. These trials are critical to establishing the safety and efficacy of a drug prior to approval. However, weaknesses in FDA’s oversight of these trials have been reported by the HHS OIG. For example, the OIG recently reported on weaknesses in FDA’s ability to oversee the protection of human subjects in clinical drug trials. Among other things, the OIG found vulnerabilities, including data limitations, which inhibit FDA’s ability to effectively manage clinical trials conducted through its Bioresearch Monitoring Program. It also determined that few inspections are conducted of clinical trial sites—only 1 percent of such sites during fiscal years 2000-2005. We have also raised concerns regarding FDA’s oversight of clinical trials. For example, we reported on FDA’s oversight of these trials involving elderly persons and found many instances where FDA’s analyses of differences in the safety and effectiveness of particular drugs for various age groups were not reported in its clinical review summaries, even though the drugs were used to treat conditions more prevalent among the elderly.7 Similarly, we cited weaknesses involving the reporting of clinical trial results by drug companies that did not adequately distinguish the results of male participants from female participants.8 Because there are differences in the way men and women absorb, distribute, and metabolize drugs, it is important that clinical trials track whether men and women face different drug-related health risks. We found that FDA did not take full advantage of available data to learn more about the effects of drugs in women and recommended that the agency take steps to ensure that drug sponsors comply with regulations regarding the presentation of results by gender. We further recommended that FDA consistently and systematically discuss gender differences in their written reviews of new drug applications. FDA has not implemented this recommendation, which we made in 2001.

If I were an Senator or Congressman looking to make a name for myself in healthcare – this report is where I'd begin to look for my reform ideas.  

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